Previously confirmed histological diagnosis of malignant brain tumours (glioma), with current clinical or imaging evidence for first or second recurrence
Conditions
Interventions
Product Name: [131I]-L-4-Iodophenylalanine
Pharmaceutical Form: Infusion
Current Sponsor code: 131 I-IPA
Other descriptive name: 4-IODOPHENYLALANINE I-131
Concentration unit: GBq gigabecquerel(s)
Conc
Sponsors
Kepler Universitätsklinikum Linz Neuromed Campus
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Previously confirmed histological diagnosis of HGG IDH1/2 wildtype, with current clinical or imaging evidence for first or second recurrence according to modified RANO criteria (2017). History of standard therapy (debulking surgery, followed by radio-chemotherapy (50–60 Gy in 2 Gy fractions, temozolomide). Patients treated with Radiotherapy alone in 1st line according to the elderly GBM protocol could also be included. 2. Interval since end of 1st line XRT =6 months 3. Amino acid-based molecular imaging (preferably 18F-FET-PET indicating pathologically increased amino acid uptake inside or in the vicinity of the tumour, clearly discernible from background activity. Surgery for relapsed tumour is allowed, if postoperative MRI and/or PET shows residual tumour in contrast enhanced MRI and/or 18F-FET-PET. 4.Current indication for repeat radiation therapy as discussed at the multidisciplinary neuro-oncological tumour board meeting. 5. Gross tumour volume (GTV) of up to 5 cm diameter, clinical target volume (CTV) 0.5 cm margin and planning target volume (PTV) = 0.5 cm margin Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Primary XRT dose > 60 Gy 2. Doses to organs at risk defined by Yasar and Tugrul (2005) exceeded or reached by prior radiation therapy; e.g. cumulative total dose on the optical chiasm >54 Gy for 2 Gy/fraction, a/ß=2 3. Multifocal distant recurrence, defined as tumour lesion outside the primary XRT field, as evidenced by amino acid-based PET imaging or CEMRI. 4. Prior treatment with brachytherapy 5. Prior treatment with bevacizumab 6. Localisation of tumour related to brain stem or axis, unless sufficient reserve capacity (e.g. remnant resection cavity, marked atrophy) to accommodate possible post–procedural tissue reactions, or pretherapeutic consent for emergency trepanation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and tolerability of intravenous 131I-IPA administered concomitantly to Re- XRT in recurrent HGG;Secondary Objective: 1. To measure the quality of life before and after therapy 2. Response assessment using mRANO criteria 3. Time to Progression, Progression free Survival 4. Overall survival;Primary end point(s): safety and tolerability of intravenous 131I-IPA administered concomitantly to Re- XRT in recurrent HGG;Timepoint(s) of evaluation of this end point: During the study in scheduled visits up to one year after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. To measure the quality of life before and after therapy 2. Response assessment using mRANO criteria 3. Time to Progression, Progression free Survival 4. Overall survival;Timepoint(s) of evaluation of this end point: During the study in scheduled visits up to one year after treatment | — |
Countries
Austria
Contacts
Public ContactDepartment of Neurooncology
Kepler Universitätsklinikum Linz Neuromed
Outcome results
None listed